A Study Evaluating the Efficacy and Safety of Sildenafil in Patients With Erectile Dysfunction Receiving Hemodialysis

• rate of successful sexual intercourse (number of attempts at sexual intercourse, number of successful attempts and percentage of attempts that were successful) [ Time Frame: Baseline to Week 10 ] [ Designated as safety issue: No ]
• response to Partner's Satisfaction Questionnaire (optional) [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
• total Score of Quality of Life and erectile dysfunction questionnaire [ Time Frame: Baseline and Week 10 ] [ Designated as safety issue: No ]
• monitoring of adverse events (AEs) and measurement of sitting blood pressure and heart rate [ Time Frame: Baseline, and Weeks 2, 4, 6, and 10 ] [ Designated as safety issue: Yes ]
• response to Question 1 of the Global Efficacy Assessment Question [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
• responses to questions of the IIEF [ Time Frame: Baseline and Week 10 ] [ Designated as safety issue: No ]

The study was done to evaluate the efficacy, safety, and tolerability of orally administered sildenafil taken as needed about one hour before sexual activity after a 10-week period in male outpatients with erectile dysfunction and severe renal failure who were on hemodialysis.

• Erectile Disfunction
• Hemodialysis

• Drug: placebo
  Placebo comparator to be given per protocol.
• Drug: sildenafil
  oral sildenafil citrate at an initial dose of 25 mg, which could have been up-titrated to 50 mg at Visit 3 based on the patient's efficacy, safety and tolerability responses; at Visits 4 and 5, the dose could remain the same, be increased to 100 mg, or decreased to 25 mg depending on the safety, efficacy, and tolerability

• Placebo Comparator: placebo
  Intervention: Drug: placebo
• Active Comparator: sildenafil
  Intervention: Drug: sildenafil

Inclusion Criteria:

• Included patients had been in a stable relationship with a female partner for at least 6 months
• A diagnosis of renal failure, with creatinine clearance ≤10 ml/min; been under hemodialysis for at least 6 months prior to the screening period, and a clinical diagnosis of erectile dysfunction (ED) as confirmed by International Index of Erectile Function (IIEF-5) score of <21 and defined as an "incapacity to obtain and/or maintain an erection sufficient for a satisfactory sexual performance".

Exclusion Criteria:

• Patients in regular use of nitrates or nitric oxide donor drugs, or have received a prescription to use these substances in any formulation
• Patients with genital anatomic malformation that may significantly impair erection (e.g., serious penile fibrosis)
• Patients with other sexual disorders (e.g., hypoactive sexual desire) considered as a primary diagnosis, with a coexisting ED diagnosis, including patients receiving anti-androgenic therapy whose libido has not been preserved; patients receiving hormonal replacement therapy for at least 6 months, or whose dose has not been stabilized within the last 6 months before the study screening period
• Patients with diabetes mellitus presenting poor control of their diabetes and/or proliferate diabetes retinopathy.